Product event summary: the afapro28 balloon catheter with lot number 14851 was returned and analyzed.External visual inspection of the electrical connector showed, pins 13,14,15,16 on the electrical umbilical connector was bent.Catheter smart chip data could not be verified due to the bent pins.The performance test could not be performed with console due to the bent pins.The catheter was defective.During inspection of the shaft segment, a guide wire lumen kink/twist was observed 1.008 inches proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen kink and bent pins.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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